The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring.

The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

Device Description

The ZZOMA Positional Sleeper is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam (Figures 1 and 2). It is contained in a backpack type material with an associated Velcro® elastic belt. The device is worn on the back, with the elastic belts brought around each side of the subject and secured anteriorly with the adjustable straps. The particular size and wedge-shaped design on both sides of this device keeps the subject comfortably positioned on their side, and prevents him/her from assuming the supine position. The ZZOMA has a firm inner core made of foam and the outer part of the device is covered in nylon, and the part that touches the subject's body is cotton covered with a coating of PVC dots that help keep the ZZOMA in place while you sleep.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state formal "acceptance criteria" for the device, and the direct performance metrics are relative to CPAP therapy. However, the primary objective of the study can be interpreted as the functional "acceptance criteria" for the device's effectiveness.

Acceptance Criteria (Inferred from Study Objective)	Reported Device Performance (ZZOMA Positional Sleeper)
Non-inferiority to CPAP therapy on the apnea-hypopnea index (AHI) after one night of therapy in patients with positional obstructive sleep apnea (OSA).	In patients with positional OSA, positional therapy is equivalent to CPAP therapy at normalizing the AHI, in addition to decreasing the AHI by >30%.
Ability to maintain the patient in the lateral position during sleep.	Similar to CPAP therapy in regards to effects on sleep quality and nocturnal oxygenation.
Initial effects on AHI and sleep quality comparable to CPAP therapy.	There is no significant difference between positional therapy and CPAP therapy at maintaining patients in the non-supine position throughout the night.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The text states, "There were 4 major findings in this study: 7/11 patients with positional OSA...". This indicates the study involved 11 patients with positional OSA.
Data Provenance: The text does not specify the country of origin of the data. The study was conducted to examine the non-inferiority of the device, which typically implies a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The text does not provide information on the number of experts used or their qualifications for establishing the ground truth. It mentions a "clinical study" but doesn't detail the methodology for expert
review or assessment of sleep parameters.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The text does not provide information on any adjudication method used for the test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is a physical positional sleeper for OSA, not an AI-assisted diagnostic or interpretive tool that would involve human "readers." The study compares the device's effectiveness to CPAP therapy, not to human interpretation with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The ZZOMA Positional Sleeper is a physical device, not an algorithm. Its performance is measured directly by its physiological impact on the patient during sleep.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth or primary outcome measure for the study was the apnea-hypopnea index (AHI) and the patient's sleep position, which are objective physiological measurements obtained during sleep studies. This falls under outcomes data or physiological measurements.

8. The sample size for the training set

The text does not provide information on a "training set" as this is a physical device being evaluated in a clinical trial, not a machine learning algorithm.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as #8.

Summary

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K100/60

Exhibit 1 510(k) Summary

1 510(k) Summary
MAY 1 1 2010

Date of Summary Preparation: May 7, 2010

1.2	Submitter:	Joseph Crocetti, DOSleep Specialists, LLCP.O. Box 610Abington, PA 19001Phone: (610) 304-6408E-mail: info@zzomasleep.com
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1.3 Trade Name: ZZOMA Positional Sleeper

Classification Name, Product Code, Class, Classification Reference: 1.4

Common Name	Product Code	Class	21CFR §
ZZOMA	MYB	II	872.5570
Positional
Sleeper

1.5 Standards/Special Controls:

None

1.6 Indications for Use:
The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate obstructive sleep apnea (OSA) and to reduce or alleviate snoring.

The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

1.7 Device Description:

Substantially Equivalent Commercially Available Devices: · 1.8

The ZZOMA Positional Sleeper device is substantially equivalent to the predicate device described herein with respect to indications for use:

· Sleep Devices, Inc. Sona Pillow - K040161

Aeolus International Corporation, Sniff Position Pillows/Popitz Pillows - K023010

The predicate devices (Sona Pillow and Sniff Position Biollows/Popitz Pillows) are commercially available and marketed Class II devices.

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1.9 Substantial Equivalence Comparison:

ZZOMA Positional Sleeper	Predicate Sleep Devices,Inc, Sona Pillow –K040161	Equivalency
The ZZOMA Positional Sleeper isindicated for use and intended fornon-professional, over-the-counteruse and for professional use for thetreatment of mild to moderateobstructive sleep apnea (OSA) and toreduce or alleviate snoring.	May stop or decrease snoringMay be used to treat mildobstructive sleep apneaMay improve the quality of sleep	Same - Treatsmild obstructivesleep apneaSame –regardingeffects onsnoringDifferent – does
		not disruptsleep qualityDifferent –
		treats both mildand moderatesleep apnea

INDICATIONS FOR USE

METHODOLOGY

ZZOMA Positional Sleeper	Predicate	Equivalency
Positions on the back	Positions on the head and neck	Same - bothdevices preventsubjects fromsleeping ontheir backs
		Different -Pillow positionshead, Zzomapositions back

PERFORMANCE

ltem	ZZOMA PositionalSleeper	Predicate	Equivalency
Storage	Room temperature	Room temperature	Same
Positioning	Keep subject off back whilesleeping	Keep subject off backwhile sleeping	Same

A clinical study was conducted to examine the non-inferiority of the Zzoma Positional Sleeper and CPAP therapy on the apnea-hypopnea index after one night of therapy in patients with positional obstructive sleep apnea.

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i A secondary objective was to evaluate the ability of the Zzoma Positional Sleeper to maintain the patient in the lateral position was to evaluate the ability of in objective is to evaluate the initial effects of the in the lateral position during sloop. Thistier observer, and compare it to initial effects seen with CPAP therapy.

There were 4 major findings in this study: 1) in patients with positional OSA, positional therapy is There were 4 major in this study. 7/11 pations with in addition to decreasing the AHI by > equivalent to CPAP therapy at nomalizing the Arr o - regards to effects on sleep quality and nocturnal 30%, 2) positional meraly is siniliar to Or X. " trerapy in 70garane AHI in patients with positional oxygenation, of there is milliffer the at maintaining patients in the non-supine position throughout the night.

1.10 Indications and Contraindications:

Relative indications and contraindications for the ZZOMA Positional Sleeper and positional commercially relative indications and contrained uses (treating moderate positional sleep apena) are similar.

1.11 Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Sleep Specialists, LLC concludes that the new information provided in the pro manect nosffective and substantially equivalent to the predicate devices as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a stylized symbol. The symbol is a representation of a human figure embracing or protecting another person, conveying a sense of care and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAY 1 1 2010

Sleep Specialists, LLC c/o Mr. Howard Mann 1 Congressional Drive, Apt C Greenville, Delaware 19807

Re: K100160

Trade/Device Name: ZZOMA Positional Sleeper Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: MYB Dated: March 29, 2010 Received: April 6, 2010

Dear Mr. Mann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Howard Mann

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Rua. Hien, M.D.

Malvina B. Eydelman, M Director Division of Ophthalmic, Neuroloical, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT B Indications for Use Statement

Indications for Use .

510(k) K100160:

Device Name: ZZOMA Positional Sleeper

Indications for Use:

The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

Caution: Federal law restricts the device to sale by or on the order of a physician or dentist.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anatolet

Page 1 of

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K100160

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”